Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
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The manufacturer has received reports of the capacitor within the oxygen concentrator shorting and causing heat damage to the concentrator.
Model Catalog: IRC501C (Lot serial: 97A); Model Catalog: IRC50102C (Lot serial: 97A); Model Catalog: IRC501C (Lot serial: THROUGH 95L 96A THROUGH 96L); Model Catalog: IRC50102C (Lot serial: THROUGH 95L 96A THROUGH 96L); Model Catalog: IRC501C (Lot serial: ALL S/NS 94K AND 94L 95A); Model Catalog: IRC50102C (Lot serial: ALL S/NS 94K AND 94L 95A)